Former CDRH director Dan Schultz had this to say when reflecting on his tenure at the center's helm: “When I look back over the last five years, I see many CDRH accomplishments to reflect on and many unfinished tasks still ahead. The implementation of device user fees with its influx of resources and people has led to a more efficient and consistent premarket review process. Scorecards, project management plans, and extensive IT innovations have allowed us to track, measure, and adjust our programs while adding increased accountability. Science prioritization has both strengthened our research enterprise and ensured that science and regulation are firmly integrated in all of our many activities. And the postmarket transformation process has provided an opportunity to fundamentally rethink the way that risk/benefit information is collected, analyzed, and acted upon using all available resources within the center and utilizing available data and opportunities for collaboration outside the center as well. The matrix as both a construct and a concept is identifying and implementing new paths to a more effective CDRH and better risk management for the products we regulate. “There is always more to be done. Developing methodologies for quantitative decision making across the product life cycle will not only allow us to make better decisions but will enhance our ability to explain and replicate those decisions. Working within the center and with other agency colleagues to prioritize and streamline the processes for regulation, policy, and guidance development will provide greater clarity both internally and externally as to the responsibilities that each of us has in maximizing the safety and effectiveness of the products that we regulate. Linking internal performance goals to public health outcomes and budget allocations in a way that can be measured and communicated will enhance the center’s fiscal strength and our ability to advance public health through access to better and safer medical devices and radiological products.” —Jim Dickinson (Washington Wrap-Up, MD&DI October) [Read more about Schultz's resignation in Jim Dickinson's Washington Wrap-Up column in the October issue of MD&DI]